Browse Device Recalls
39,885 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,885 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 39,885 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 1, 2026 | 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 | Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been... | Class II | Aniara Diagnostica LLC |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 | Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been... | Class II | Aniara Diagnostica LLC |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jun 30, 2026 | GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the ... | The module did not undergo electrical safety tests and functional tests during production. | Class II | Maquet Critical Care AB |
| Jun 30, 2026 | Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: ... | Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Jun 30, 2026 | Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas St... | Due to incorrect machining of peripheral screw hole resulting in potential for improper engagemen... | Class II | restor3d Inc. |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 cou... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 30, 2026 | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507;... | Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cu... | Class I | Baxter Healthcare Corporation |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Produc... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Prod... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, ... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 30, 2026 | Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions... | Potential for breach in sterile barrier of device packaging. | Class II | Boston Scientific Corporation |
| Jun 30, 2026 | Merge OrthoPACS, medical imaging diagnostic workstation | Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a d... | Class II | Merge Healthcare, Inc. |
| Jun 30, 2026 | Merge PACS, medical imaging diagnostic workstation | Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a d... | Class II | Merge Healthcare, Inc. |
| Jun 30, 2026 | Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions an... | Potential for breach in sterile barrier of device packaging. | Class II | Boston Scientific Corporation |
| Jun 30, 2026 | Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: ... | Potential for breach in sterile barrier of device packaging. | Class II | Boston Scientific Corporation |
| Jun 30, 2026 | SnapshotGLO Wound Imaging Device, Model KB100, KB100AA. | The software controlling the wound imaging device's battery charging circuit was not designed to ... | Class II | KENT IMAGING, INC. |
| Jun 30, 2026 | Rapid Refill Continuous Injection System, UPN M00566001 | Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There ... | Class II | Boston Scientific Corporation |
| Jun 29, 2026 | American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: T... | The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubb... | Class II | American Contract Systems Inc |
| Jun 29, 2026 | American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TN... | The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubb... | Class II | American Contract Systems Inc |
| Jun 29, 2026 | American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TN... | The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubb... | Class II | American Contract Systems Inc |
| Jun 29, 2026 | American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: L... | The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubb... | Class II | American Contract Systems Inc |
| Jun 29, 2026 | Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038... | Firmware issue potentially leading to loss of geometry movements. | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jun 29, 2026 | Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Int... | Carotid stent and post-dilation balloon system with integrated embolic protection system has an i... | Class II | Contego Medical, Inc |
| Jun 29, 2026 | GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph | Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an ... | Class II | GE Medical Systems Information Technologies Inc |
| Jun 26, 2026 | Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product ... | Potential of failing to trigger clinical scan during Bolus Tracking. | Class II | Philips Healthcare (Suzhou) Co., Ltd. |
| Jun 26, 2026 | ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 | A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short... | Class II | Erbe USA Inc |
| Jun 26, 2026 | Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D... | Black depth markings may detach from the outer sheath of the coaxial dilator introducer component... | Class II | Galt Medical Corporation |
| Jun 26, 2026 | Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Ca... | Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Cali... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Jun 26, 2026 | REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic install... | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results... | Class II | Beckman Coulter Inc. |
| Jun 26, 2026 | REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the foll... | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results... | Class II | Beckman Coulter Inc. |
| Jun 26, 2026 | Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 1044539... | out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant C... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Nu... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog ... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 ... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 ... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number:... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.